Outsourcing in Clinical Trials USA Virtual Conference

Biography: Ken is the Director of Sponsored Research and Associate Professor at the Tufts Center for the Study of Drug Development, and Chairman of the Center for Information and Study on Clinical Research Participation, a non-profit organization that he founded to raise public and patient awareness of the clinical research enterprise. He is founder and owner of CenterWatch, and an owner and board member of the Metrics Champion Consortium. A well-known speaker at symposia, universities, and corporations, Ken has published extensively in peer-reviewed journals, books and in the trade press.  He has been an active DIA member for 25 years and has held board appointments in the private and public sectors.  Ken earned his MBA from Northwestern University.

Session Details: Drug Development Trends and their Impact on Clinical Trial Execution 01-10-2020, 1:30 pm View In Agenda

Biography: Matt Weinberg is Director of Strategic Sourcing for Agios Pharmaceuticals, a biotech company focused on developing treatments for cancer and rare diseases through scientific leadership in the field of cellular metabolism.  The Agios Sourcing team is small but mighty.  Matt has responsibility for leading the group and also supports the Clinical Development and Commercial functions.

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Biography: Hyun Kim is currently the Head of Clinical Operations at AOBiome, a leading clinical-stage microbiome company focusing on the research and development of a novel class of drugs for inflammatory conditions, CNS disorders, and other systemic diseases. Prior to that, he has led inflammation, orphan disease, and oncology clinical programs at Pfizer as a Development Director. Prior to Pfizer, he was involved with a few smaller companies and startups, including Anika Therapeutics, Transport Pharmaceuticals, Olympus Biotech and various clinical, regulatory, and medical affairs consulting roles in tissue repair, infectious diseases, inflammation, and neurology across small molecule, biologics, drug delivery, medical device, and combination product platforms. He started his career at Genetics Institute in Cambridge, MA, which later became Wyeth and Pfizer, where he developed bone morphogenetic proteins based biologics for various musculoskeletal indications. He attended Brown University where he studied Biomedical Engineering for undergraduate and masters degrees, and a PhD in Medical Science.

Session Details: Determining how to find the right partner to conduct your early clinical development study 30-09-2020, 11:00 am View In Agenda

Biography: Behtash Bahador is an Associate Director at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

Session Details: This is Not a Trend: Exploring Why Patient-Centered Clinical Research Will Continue to Change the Research Paradigms of the Past and the Impact it Can Have 30-09-2020, 1:00 pm View In Agenda

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Biography: Colleen Graham has over 20 years of extensive Clinical Research experience. She began her research career at a Clinical Site, and has held a variety of operational positions from an Ethical Review Board to CROs and Pharmaceutical companies, both large and small. Her experience includes Phases I-IV drugs, biologics and device studies across a variety of therapeutic areas working with companies such as Biogen, Pfizer, and Takeda Pharmaceuticals. Her operational experience includes resource management, process development and she has managed large-scale global studies. Colleen is currently Director of Clinical Development Operations at Momenta Pharmaceuticals, where she responsible for clinical development of M281 in rare immune-mediated diseases.

Session Details: Deep Diving Into Outsourcing and Innovation In 2020 And Beyond 30-09-2020, 11:00 am View In Agenda

Biography: James L. Sherley, M.D., Ph.D. is the founder and director of Massachusetts stem cell biotechnology company Asymmetrex, LLC.  Asymmetrex develops and markets technologies for advancing stem cell medicine, including the first-in-kind technology for specific counting of adult tissue stem cells.  This technology is also applied to design optimized procedures for more effective manufacturing of therapeutic adult tissue stem cells at greatly reduced cost.  Dr. Sherley is a graduate of Harvard College, with a B.A. degree in biology, and the Johns Hopkins University School of Medicine, earning joint M.D. and Ph.D. degrees.  Prior to founding Asymmetrex, he held academic research appointments at the Fox Chase Cancer Center, Massachusetts Institute of Technology, and Boston Biomedical Research Institute.  Dr. Sherley’s professional awards include Pew Biomedical Research Scholar, Ellison Medical Foundation Senior Scholar in Aging Research, and NIH Director’s Pioneer Award.

Session Details: Improving the Design of Early Phase Stem Cell Clinical Trials 30-09-2020, 2:00 pm View In Agenda

Biography: Rangaprasad (Ranga) Sarangarajan, Ph.D., is the Chief Scientific Officer and SVP Clinical and Translational Sciences at BERG. He has oversight on all R&D activities and involved in the strategic planning and implementation of activities related to pharmaceutical and clinical developmental activities. . Dr. Sarangarajan is the co-inventor and co-architect of the BERG Interrogative Biology® technology; currently focused on next generation R&D innovation in the integration of artificial intelligence based analytics, bioinformatics and RWD/RWE utility for speeding up identification/validation of targets, tractability, drug discovery & pharmaceutical development. Dr. Sarangarajan has numerous US and international patents (granted and pending), covering areas of the discovery platform, cancer, neurology, metabolic diseases, diabetes, obesity and diagnostics. He has published extensively and has presented his research in national and international medical and scientific meetings. He co-authored and co-edited Cellular Respiration and Carcinogenesis, a first of its kind treatise on the role of mitochondrial function and metabolic network regulation in the etiology of cancer as it pertains to the seminal observations made by Otto Warburg. Dr. Sarangarajan has a B.S. in Pharmacy and graduate degree in Pharmaceutical Sciences from the University of Cincinnati College of Pharmacy with focus on pharmacology and toxicology. He went on to pursue post-graduate training in genetics, molecular and cell biology for several years prior to joining Massachusetts College of Pharmacy and Health Sciences (now MCPHS University) and served in capacity of Assistant/Associate Professor.

Session Details: Fireside chat: Molecular Mapping, AI and data analytics in Oncology Clinical Trials 30-09-2020, 11:00 am PANEL DISCUSSION: Novel Digital Endpoints in Clinical Research: Technology, Infrastructure, Relationship with Technology Providers 30-09-2020, 3:00 pm View In Agenda

Biography: Makarovskaya Maria has 20 years of experience in clinical business operations in Pharmaceutical/Biotech industry. Areas of expertise include: strategic outsourcing, vendor and relationship management, contract management, financial analysis, global procurement and project management with emphasis on clinical research. She started her career at a site at Rhode Island Hospital and continued at various biotech/pharmaceutical and device companies, including Vertex, Sepracor, Molecular Insight Pharmaceuticals, Boston Scientific, Cubist, Infinity, Tesaro. She holds a Master’s Degree in Liberal Arts from Moscow Linguistic University and Paralegal Diploma from National Academy for Paralegal Studies from Albertus Magnus College, CT.

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Biography: Biopharmaceutical market research analyst with experience across a host of therapeutic areas, including dermatology, ophthalmology, genitourinary, oncology, anti-infectives, and niche and rare diseases specifically in the hepatitis C, HIV, vaccine, NASH, and cystic fibrosis spaces. I specialize in corporate financial analysis, market forecasting, primary and secondary market research, and drug pipeline and portfolio analysis. I have been featured in multiple peer-reviewed scientific publications and have presented data at scientific conferences.

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Biography: Revati Tatake currently serves as a Global Director of Databases and Analytics at GlobalData, where her primary responsibilities are to lead the development and continuous enhancement of integrated databases and analytical tools for providing competitive and business intelligence for pharmaceutical and biotechnology sectors Revati has more than 20 years’ experience, both in academic research and the healthcare industry, during which time she focused on basic and clinical research, drug discovery and competitive intelligence projects across many therapeutic areas.  After academic career at Tata Cancer Research Institute and the University of Connecticut Health Center, she began her healthcare industry career at Boehringer Ingelheim Pharmaceuticals, where she led drug discovery projects involving small molecules, gene therapy and cell therapy for cardiovascular diseases, Rheumatoid arthritis and Diabetes.  In addition to leading drug discovery projects, Revati co-chaired novel target identification group, scouted novel technologies for enhancing drug discovery efforts, established collaborations with experts in academic institutions to complement internal projects and evaluated in-licensing opportunities for their scientific and technical merit.  She is a co-inventor on several issued US patents and applications related to the projects on cell and gene therapies. Before joining GlobalData, Revati worked at Citeline, where she was involved in competitive intelligence and analytics of clinical trials and pharmaceutical products. Revati holds a PhD in Tumor Immunology from Tata Cancer Research Institute. She was a post-doctoral fellow at the University of Connecticut Health Center.

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Frank Leu is a Co-Founder and CEO of Novapeutics at Philadelphia, PA - a biopharma spun-out from the University of Pennsylvania, developing a first-in-class small molecule beta-cell restoration curative for type 2 diabetes. Prior, Frank was at a specialty pharma Verto Institute, developing biologic therapeutics for treating the neuroendocrine cancer. Frank graduated with a Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences in 2001, and then post-doc in a Howard Hughes Medical Institute laboratory at the Rockefeller University in molecular enzymology. He has served as an adjunct instructor at the Rutgers Cancer Institute of NJ, and is an adjunct professor at the pharmacology department of the Thomas Jefferson Medical University. Frank also founded BioPharMatrix developing blockchain solutions to lifescience innovations at all phases, and serves as advisor to the Pennovations center working with 1776 / Benjamins Desk. Frank is a thought leader in the blockchain architecture innovations in the life-sciences and drug development, Frank serves on multiple advisory boards and frequently served as chairman, speaker, moderator, and facilitator for many life-sciences and drug development events.

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